Global Data Moderna has announced that the FDA will initiate the review of its seasonal influenza vaccine candidate, mRNA-1010. This announcement comes one week after the FDA’s Center for Biologics Evaluation and Research (CBER) notified Moderna that it would not initiate a review of mRNA-1010, and a Refusal-to-File (RTF) letter was issued, citing concerns over the choice of the vaccine comparator used in the Phase III trial. If approved, mRNA-1010 will be the first seasonal influenza mRNA vaccine on the market. This could transform the seasonal influenza vaccines market, as the utilisation of mRNA technology in influenza vaccines will improve vaccine effectiveness. Influenza vaccines produced via mRNA technology will have a shorter production time than egg-based vaccines, cell-based vaccines, or recombinant vaccines, which are the seasonal influenza vaccines currently on the market. This decrease in production time means that the vaccines can be made closer to the start of flu season, thereby allowing for a better match to that season’s circulating influenza strains. Likewise, Moderna has announced that, pending the FDA’s approval of mRNA-1010, it will be available for a subset of patients in time for the 2026/2027 influenza season. mRNA-1010 has also been accepted for regulatory review in the EU, Canada, and Australia.
FDA reversal on mRNA-1010 could transform the seasonal influenza vaccines market
- Published Feb 25, 2026